FDA Submission Date definition

FDA Submission Date means the earlier of (i) the date that the EV BLA is submitted to the FDA and (ii) the date that the TV BLA is submitted to the FDA.
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FDA Submission Date means the date that the SGN-CD33A BLA is submitted to the FDA.
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FDA Submission Date means the date on which the Tucatinib NDA is submitted to the FDA. 182894448 v14
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Examples of FDA Submission Date in a sentence

  • Subject to Sections 4(b) and 4(c) of the Plan, the Target Award Value applicable to a Participant shall be the Target Award Value contained in the Target Award Value Table for the Participant’s job level tier as of the FDA Submission Date.

  • Absent any determination by the Committee to the contrary, each Employee who is newly hired after March 31, 2010 and before the FDA Submission Date and qualifies as an Eligible Employee shall automatically be deemed a Participant and shall be eligible to participate in the Plan for the portion of the period beginning with such individual’s first day of employment until the FDA Submission Date.

  • Except with respect to Stock Awards granted under the Plan to a Participant who is a Covered Employee, if a Participant is promoted after March 31, 2010, but prior to the FDA Submission Date to a position with higher Target Award Value(s), then such Participant’s Target Award Values shall be increased by a prorated amount (based on the effective date of such individual’s promotion through the FDA Submission Date).

  • In addition, except with respect to Stock Awards granted under the Plan to a Participant who is a Covered Employee, prior to the determination of Actual Award Values, the Committee may otherwise increase the Target Award Value of any Participant to reflect a change in the Participant’s responsibility level or position prior to the FDA Submission Date.


More Definitions of FDA Submission Date

FDA Submission Date means the date that the Company submits the Brentuximab Vedotin NDA with the FDA.
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Related to FDA Submission Date

  • Bid Submission Date means the last date by which the City will accept Bids for an Invitation For Bid.

  • Submission Date means the date on which You Submit a Contribution to Us.

  • Submission Deadline means 1:00 P.M., New York City time, on any Auction Date or such other time on any Auction Date as may be specified by the Auction Agent from time to time as the time by which each Broker-Dealer must submit to the Auction Agent in writing all Orders obtained by it for the Auction to be conducted on such Auction Date.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Bid Submission Requirement means a task a Prospective Contractor must complete when submitting a bid response. These requirements will be distinguished by using the term “shall” or “must” in the requirement.

  • Submission Location means the submission location identified as such in the Summary of Key Information.

  • Admission Date has the meaning set forth in Section 10.06.

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Notification Date means 30 days from an Account statement date (see section 6.3).

  • Extension Determination Date means, in respect of a Series of Covered Bonds, the date falling two Business Days after the expiry of seven days from (and including) the Final Maturity Date of such Covered Bonds.

  • Firm Transmission Feasibility Study means a study conducted by the Transmission Provider in accordance with Tariff, Part II, section 19.3 and Tariff, Part III, section 32.3.

  • Publication Date means an Ordinary Publication Date or an Extraordinary Publication Date, as the case may be.

  • Delivery Period Termination Date Has the meaning specified in the Related Pass Through Trust Supplement.

  • Inclusion Date means, with respect to any Vehicle, the date that is three months after the earlier of (i) the date such Vehicle became a Redesignated Vehicle and (ii) if the Manufacturer of such Vehicle is a Bankrupt Manufacturer, the date upon which the Event of Bankruptcy which caused such Manufacturer to become a Bankrupt Manufacturer first occurred.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • continuing candidate means any candidate not deemed to be elected, and not excluded,

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Required Disclosure Date means (x) if such Buyer authorized the delivery of such Confidential Information, either (I) if the Company and such Buyer have mutually agreed upon a date (as evidenced by an e-mail or other writing) of Disclosure of such Confidential Information, such agreed upon date or (II) otherwise, the seventh (7th) calendar day after the date such Buyer first received any Confidential Information or (y) if such Buyer did not authorize the delivery of such Confidential Information, the first (1st) Business Day after such Buyer’s receipt of such Confidential Information.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Mitigation Study Period means the duration of time extending six consecutive Capability Periods and beginning with the Starting Capability Period associated with a Class Year Study, Additional SDU Study, and/or Expedited Deliverability Study. For purposes of Section 23.4.5 of this Attachment H, “Mitigated UCAP” shall mean one or more megawatts of Unforced Capacity that are subject to Control by a Market Party that has been identified by the ISO as a Pivotal Supplier. For purposes of Section 23.4.5 of this Attachment H, “Mitigation Net CONE” shall mean the capacity price on the currently effective ICAP Demand Curve for the Mitigated Capacity Zone corresponding to the average amount of excess capacity above the Mitigated Capacity Zone Installed Capacity requirement, expressed as a percentage of that requirement, that formed the basis for the ICAP Demand Curve approved by the Commission.

  • Evaluation Date shall have the meaning ascribed to such term in Section 3.1(s).

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken